Corporate Presentation Transforming Discovery Research into Innovative Medicines through Value-Based Partnership CreaGen, Inc. 299 Washington Street Woburn, MA 01801
CreaGen, Inc. Our Goal is to “Create A New Generation of Small Molecules” Through efficient and value-driven partnerships 2
Vision � Offer true collaborative services to biotech, pharmaceutical companies and Federal Research Institutes to accelerate their discovery programs � Build our reputation by exceeding customer expectations 3
Resources � Established in 2003 � Corporate Headquarters: 299 Washington Street, Woburn, MA � Scientists: Fifteen experienced chemists total, many with more than ten years in the pharmaceutical industry � Existing laboratories: ~ 25,000 sq feet: newly expanded in January 2018 � Equipment: Waters LC-MS, Varian NMR (300 MHz), Waters auto purification system, Agilent analytical and Preparative HPLCs, Isco Combi-flash systems, TCAMs for parallel synthesis, Microwave synthesizer, Genevac evaporators, SFC Chiral Chromatography � Library accessibility: online journal subscriptions, SciFinder and Beilstein/Crossfire access 4
Team � Raj (SB) Rajur, PhD, Founder & CEO 30 Years of academic, industrial and management experience: ArQule, Millipore, Boston College, Northeastern University, Massachusetts General Hospital and Harvard Medical School � Hwa-OK Kim, PhD, Director of Chemistry 30 Years of industrial and management experience: Aurigene Discovery Technologies, Molecumetics, Marion Merrell Dow and New Mexico State University � Venugopal Rao, PhD, Associate Director of Chemistry 20 Years of industrial and project management experience: Pharmacopeia, Microbiotix, Indian Institute of Chemical Technology, 5
SAB Team � Norton P. Peet, PhD, 40 Years of industrial and management experience: Aurigene Discovery Technologies, ArQule, Aventis, Marion Merrell Dow, University of Nebraska and Massachusetts Institute of Technology � Robert Perni, PhD, 30 years of industrial and management experience: Vertex Pharmaceuticals, Sirtris Pharmaceuticals, Sterling Winthrop, Avid Therapeutics, Dartmouth College, Northeastern University, University of Rochester � Mark Tebbe, PhD, 30 years of Industrial and management experience: Co-founder of Quench Bio with Atlas Venture and of Arix Bioscience, EIR at Atlas Ventures, Quartet Medicine, Forma Therapeutics, Eli Lilly, Stanford University and University of Notre Dame. � Vinod Patel, PhD, 25 years of industrial experience: Founder, TME therapeutics, Amgen, Kinetix pharmaceuticals, Sanofi-Genzyme and University of Nottingham. 6
Expertise Medicinal Chemistry: � Small Molecules, High Throughput parallel library synthesis and purification � Lead Generation and Lead Optimization � Conjugation Chemistry, Antibody Drug Conjugates (ADC) � Macrocycles and Macrocyclic libraries. Cyclic peptides � Nucleosides and Nucleotides, Peptides and Peptide Nucleic Acids (PNA) � Carbohydrates and unnatural amino acids Analytical Chemistry: � High Throughput purification and analysis 7
Why Collaborate with CreaGen � CreaGen is a US based company located in Massachusetts � CreaGen has an established track record with biotech and large pharmaceutical organizations � Interdisciplinary strengths at CreaGen insure that customers receive the best value for their investment CreaGen’s Competitive Advantage: � Flexibility, competitive pricing and fast turnaround time � Dedicated project teams and segregation of projects � Special request capabilities � Automated parallel synthesis and separations � Customized data input and output � Multiple sample delivery formats: dry, in solution, standardized amounts/concentrations, multiple copies, etc. 8
Services CreaGen performs services that are: --project-based --FTE-based --collaboration-based • Medicinal chemistry and lead optimization • Building blocks/scaffolds/key intermediates • Customer tailored focused libraries • High throughput purification and QC solutions 9
Case studies: Representative Examples CS I: Multinational Pharma (Oncology) : Lead Optimization Project requirements: • Design and optimize leads, synthesize novel analogs of the leads for weekly screening • Provide all medicinal chemistry expertise to client in designing new analogs and libraries. Explore new synthetic routes. Accomplishments: • 3-Year collaboration FTE based contract • Provided more than 600 compounds and many novel scaffolds during the tenure of the program. True extension of customer’s chemistry program CS II : Multinational Pharma : Antibody Drug Conjugates (ADC) Project requirements: • Design and synthesize novel linkers. Conjugate novel small molecules and drug candidates to linkers. Introduce reactive functionalities on the linker to conjugate to antibodies. • Provide conjugation chemistry expertise to client. Synthesize libraries of small molecules. Explore new synthetic routes. Accomplishments: • 2-Year FTE based collaboration • Provided several conjugates to client for screening. Developed several novel hydrophilic molecules to conjugate to antibodies to minimize aggregation. True extension of customer’s ADC program 10
Case studies: Representative Examples CS III: Biotech. (Anti-infective): NIH & funded projects: (CreaGen -subcontractor) Project Requirements: • Design and synthesize novel scaffolds and develop new and efficient routes for the synthesis • Provide multi-gram quantities of final compounds for in vivo tox studies with aggressive timeline • Perform process development for multi-step synthesis of scaffolds and lead molecules Accomplishments: • Five year collaborations: Provided 20 scaffolds and associated libraries and several multigram scale non-GMP compounds for in vivo tox studies CS IV : Biotech. (Anti-infective): Lead Optimization Project requirements: • Function as medicinal chemistry department • Provide all medicinal chemistry expertise to client in designing new analogs • Develop SAR and interpret weekly screening results with client and suggest new ideas Accomplishments: • Expanded collaboration to 8 FTEs: company sold to Biota Australia 11
Case study: Representative Examples CS V: NIH a) NCATS: Synthesis of commercial preclinical candidate Project requirements and accomplishments: • Synthesis of 10 grams of ERK inhibitor • Completed the synthesis within budget and delivered the compound on time. b) NCI: Synthesis of commercial preclinical compound Project requirements and accomplishments: • Synthesis of 10 grams of MMP inhibitor • Completed the synthesis and delivered the product on time 12
Case studies: Representative Examples CS VI : Small Biotech (Diabetes): Lead Optimization Project requirements: • Function as de facto medicinal chemistry department • Provide all medicinal chemistry expertise starting with design discussion, literature searches, hit-to-lead evaluation, SAR studies, lead optimization, identification and selection of high-value preclinical candidates Accomplishments: • Generated IP for their AMPK program in seven months • Provided a nanomolar compound and several backup compounds with activities in the micromolar range • Expanded to 4 FTEs • Project grew as milestones were delivered and the program was licensed to Debiophama 13
Small Molecule Library Synthesis (examples) Partner Biotech Multinational Pharma Small Biotech Project Hit to Lead Hit to Lead Optimization Exploratory to Hit/Lead 2.5 years 3.5years 2 years Duration 1~1.5 2~4 2~4 FTEs involved # of compounds 750 600 2500 library synthesis: 1~3 6~7 5~6 Synthetic steps solution phase parallel synthesis solution phase parallel synthesis solution phase parallel synthesis Library synthesis Method Qty of compounds 10-20mg Ave 50mg Ave 20mg Qty for scaffolds 2g to 50g 1g to 100g 1g to 30g /intermediates Purity 90 to 98% 90 to 98% 90 to 98% 1H NMR, 13C NMR, 2D NMR, LC-MS, 1H NMR, 13C NMR, LC-MS, HPLC, 1H NMR, 13C NMR, LC-MS, HPLC, Analytical data HPLC, elemental analysis, elemental analysis elemental analysis, HRMS etc HRMS etc HRMS etc Filed patent: Filed patent: Resulted in Lead Optimization _ Lead Optimization _ Lead Optimization 14
CreaGen Synthesized Compounds: Various Stages in Partner Programs Therapeutic Lead Lead Clinical Phase I, II & Partner Area Discovery Optimization Candidate III Multinational Cancer Pharma Biotech Diabetes Biotech Anti-infective Biotech Anti-infective Biotech Cancer Biotech Cancer Biotech CNS Asian Biotech Cancer European Pharma Diabetes 15
CreaGen Infrastructure & Equipment 16
CreaGen parallel synthesis platform
CreaGen parallel synthesis work stations • 1, 2 and 4 position heater/shakers • Heating up to 150ºC • Variable speed vortexing • Timed shutoff • Integration with automation 18
Synthesis work stations: cont’d Parallel synthesizer High speed evaporator GeneVac ( EZ2 ) 19
CreaGen purification work stations Mass directed purification Chiral purification: SFC 20
CreaGen analytical work stations CreaGen analytical work stations TQ- LCMS Varian, 300 MHz NMR 21
CreaGen: LCMS The picture can't be displayed. 22
Summary � Competitive pricing � Excellent communication � Quality services � On-time delivery � Customer satisfaction 23
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